A US District Court judge on March 31 nullified the Food and Drug Administration (FDA) regulation on the oversight of laboratory-developed tests (LDT), agreeing with plaintiffs’ and the College of American Pathologists’ (CAP) arguments that the rule should be vacated.
“The FDA’s LDT rulemaking was burdensome, and the court rightly struck it down,” said CAP President Donald Karcher MD, FCAP. “The regulation failed to target FDA oversight and threatened patient access to countless numbers of safe LDTs by saddling laboratories with unnecessary requirements. The CAP and its members are relieved that the court agreed with our arguments.”
The CAP detailed its reasons to vacate the rule in an amicus brief filed in October 2024.